Safety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, Depressed

Official Title: “Safety and Efficacy of Olanzapine (LY170053) in the Long-term Treatment for Patients With Bipolar I Disorder, Depressed”

To assess the efficacy and safety of olanzapine in the long-term treatment for patients with bipolar I disorder, depressed.

This is an open-label, multi-center, long-term treatment study conducted only in Japanese sites. The subjects are patients who fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) (296.50=unspecified, 296.52=moderate severity, 296.53=severe without psychotic features, 296.54=severe with psychotic features), who have completed Study HGMP (NCT#00510146) and patients who did not participate in Study HGMP who have been recruited to participate in Study HGMS.

Intervention(s) in this Clinical Trial

• Drug: Olanzapine
  • 5-20 mg/day, oral, daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Pre-Olanzapine
  • Participants who received olanzapine 5-20 mg/day in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
• Experimental: Pre-Placebo
  • Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
• Experimental: New Olanzapine
  • Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.

Primary Measures

• Percentage of Participants With Adverse Events Leading to Discontinuation
  • Time Frame: Baseline through 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
    Safety Issue?: Yes

Secondary Measures

• Change From Baseline in Glucose and Lipid Panel at Week 24 or Week 48 Endpoint
  • Time Frame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
    Safety Issue?: Yes
• Change From Baseline in Weight at Week 24 or Week 48 Endpoint
  • Time Frame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
    Safety Issue?: Yes
• Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 24 or Week 48 Endpoint
  • Time Frame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
    Safety Issue?: No
• Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 24 or Week 48 Endpoint
  • Time Frame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
    Safety Issue?: No
• Change From Baseline in Clinical Global Improvement- Bipolar (CGI-BP) at Week 24 or Week 48 Endpoint
  • Time Frame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
    Safety Issue?: No
• Percentage of Participants With Emergence of Mania at Week 24 or Week 48
  • Time Frame: 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
    Safety Issue?: Yes
• Percentage of Participants With High Suicidality at Week 24 or Week 48
  • Time Frame: 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
    Safety Issue?: Yes
• Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Week 24 or Week 48
  • Time Frame: 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
    Safety Issue?: Yes
• Change From Baseline in Hemoglobin (HbA1c) at Week 24 or Week 48 Endpoint
  • Time Frame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
    Safety Issue?: Yes
• Change From Baseline in Prolactin at Week 24 or Week 48 Endpoint
  • Time Frame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
    Safety Issue?: Yes
• Change From Baseline to in QTcF at Week 24 or Week 48 Endpoint
  • Time Frame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Patients must be aged 18 to less than 75 years.
• 2. Each patient must be reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must understand the nature of the study and have provided informed consent.
• 3. All female patients must test negative for pregnancy.
• 4. Females of breast-feeding potential must agree not to breastfeed an infant during the study and for 1 month following the last dose of study drug.
• 5. Male patients who are not surgically sterilized must agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
• 6. Patients must fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR).
• 7. Patients must have experienced, in the opinion of the investigator, at least one previous manic or mixed episode, as defined in the DSM-IV-TR.
• 8. Patients must have a current Young Mania Rating Scale (YMRS) Total score =<8.

Exclusion Criteria:

• 1. Is investigator site personnel directly affiliated with this study or their immediate families.
• 2. Is a Lilly employee.
• 3. Has previously completed or withdrawn from this study or any other study investigating olanzapine.
• 4. Is pregnant or nursing.
• 5. Has a serious, unstable illness such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4599) or 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00618748

Study ID Number: 11682

ClinicalTrials.gov Identifier: NCT00618748

Health Authority: Japan: Ministry of Health, Labor and Welfare

Lilly Clinical Trial Registry